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Can 3D Printed Tablets Be Bioequivalent and How to Test It: A PBPK Model Based Virtual Bioequivalence Study for

Olha Shuklinova1,2, Gabriela Wyszogrodzka-Gaweł3, Ewelina Baran4

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3D printing enables personalized medicine, but bioequivalence testing is challenging. This study successfully used physiologically based pharmacokinetic (PBPK) modeling to virtually prove bioequivalence for 3D printed drugs, reducing the need for extensive clinical trials.

Keywords:
3D printingphysiologically based pharmacokinetic modelingropinirolevirtual bioequivalence

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Area of Science:

  • Pharmaceutical Manufacturing
  • Personalized Medicine
  • Pharmacokinetics

Background:

  • Personalized dosing requires flexible pharmaceutical manufacturing.
  • 3D printing offers potential for tailored drug release and strength.
  • Traditional bioequivalence testing for small batches is burdensome.

Purpose of the Study:

  • To demonstrate the use of 3D printing with virtual bioequivalence trials.
  • To assess the bioequivalence of 3D printed ropinirole formulations.
  • To reduce the testing burden associated with personalized drug manufacturing.

Main Methods:

  • Developed 3D printed ropinirole formulations.
  • Utilized physiologically based pharmacokinetic (PBPK) modeling and the Simcyp simulator.
  • Inputted Weibull-fitted dissolution profiles into PBPK models for virtual bioequivalence trials.

Main Results:

  • Virtual bioequivalence trials were conducted using a parallel design.
  • A study power of 80% was achieved with 125 individuals in simulations.
  • One 3D printed formulation demonstrated bioequivalence to the reference product (Polpix).

Conclusions:

  • Physiologically based pharmacokinetic (PBPK) modeling combined with 3D printing can effectively test virtual bioequivalence.
  • This approach offers a viable strategy for supporting the development of personalized drug formulations.
  • Virtual bioequivalence testing can streamline the approval process for customized pharmaceutical products.